The Creating Hope Act pediatric priority review voucher program has been wildly successful. It is critical that Congress reauthorize the program permanently so that children with serious illnesses can have hope for new therapies, better health and even possibly cures.
The Creating Hope Act establishes an incentive for drugs to be developed expressly for children with rare diseases. The incentive is a priority review voucher that can be earned by a company that develops a rare pediatric disease drug. The vouchers come with rights to faster FDA review of any other drug, including a drug that would not be for any rare pediatric diseases.
Since the passage of the Creating Hope Act pediatric priority review voucher program, the FDA has approved 19 new therapies for children with serious illnesses, two of which are for children with cancer.
Vouchers have traded for as much as $350 million, providing a significant incentive for drug development for seriously ill children. $2 billion in vouchers have been traded. Just recently, a voucher was issued to Vertex Pharmaceuticals for their development of a breakthrough therapy for cystic fibrosis that will give tremendous benfit to patients 12 years and older.
The Creating Hope Act has helped children like Emma Whitehead, who was treated with the first FDA approved drug for a gene therapy, Novartis’ Kymriah, for B-cell precursor ALL. Kyrmiah earned a voucher. In addition, Y-mABs Therapeutics is using the pediatric priority review voucher program to develop exciting new therapies for children with neuroblastoma and other pediatric cancers.
Now is the time for the Creating Hope Act to be permanently reauthorized. There is clear evidence of its impact. There are 370 days before the Creating Hope Act expires. On this fourth reauthorization, we are asking for permanency. Congress has passed two other voucher programs based on the provisions of the Creating Hope Act — for tropical diseases and medical countermeasures. Both of these voucher programs are permanent while the Creating Hope Act is not. Now is the time we make this permanent for our children!
This is the action you can take to get this bill sent to the floor of the House for a vote:
Tweet and/or call members of the Energy and Commerce Committee in order to get this bill sent to the House for a vote. Use sample below for your request:
Please approve HR. 4439, The Creating Hope Act Authorization in order to provide incentives for drug development for children with rare diseases.
|Blunt Rochester, Lisa||DE||At Large||@RepLBR||(202)||225-4165|
|Brooks, Susan W.||IN||5th||@SusanWBrooks||(202)||225-2276|
|Burgess, Michael C.||TX||26th||@MichaelCBurgess||(202)||225-7772|
|Carter, Earl L. “Buddy”||GA||1st||@RepBuddyCarter||(202)||225-5831|
|Clarke, Yvette D.||NY||9th||@YvetteClarke||(202)||225-6231|
|Doyle, Michael F.||PA||18th||@USRepMikeDoyle||(202)||225-2135|
|Eshoo, Anna G.||CA||18th||@RepAnnaEshoo||(202)||225-8104|
|Gianforte, Greg||MT||At Large||@GregForMontana||(202)||225-3211|
|Griffith, H. Morgan||VA||9th||
|Kennedy, Joseph P., III||MA||4th||@RepJoeKennedy||(202)||225-5931|
|Kuster, Ann M.||NH||2d||@AnnMcLaneKuster||(202)||225-5206|
|Latta, Robert E.||OH||5th||@BobLatta||(202)||225-6405|
|Lujan, Ben Ray||NM||3d||@RepBenrayLujan||(202)||225-6316|
|Matsui, Doris O.||CA||6th||@DorisMatsui||(202)||225-7163|
|McEachin, A. Donald||VA||4th||@RepMcEachin||(202)||225-6365|
|McKinley, David B.||WV||1st||@RepMcKinley||(202)||225-4172|
|McMorris Rodgers, Cathy||WA||5th||@CathyMcMorris||(202)||225-2006|
|Peters, Scott H.||CA||52d||@RepScottPeters||(202)||225-0508|
|Sarbanes, John P.||MD||3d||@RepSarbanes||(202)||225-4016|
|Schakowsky, Janice D.||IL||9th||@JanSchakowsky||(202)||225-2111|
|Veasey, Marc A.||TX||33d||@MarcVeasey||(202)||225-9897|
|Welch, Peter||VT||At Large||@PeterWelch||(202)||225-4115|
|Pallone, Frank, Jr.||NJ||6th||@FrankPallone||(202)||225-4671|